Navigation Links
LigoCyte Pharmaceuticals Initiates a Randomized, Double Blind, Placebo Controlled Norovirus Vaccine Study Including Live Virus Challenge
Date:9/8/2009

BOZEMAN, Mont., Sept 8 /PRNewswire/ -- LigoCyte Pharmaceuticals, Inc. announced today that it has initiated its third human clinical trial of its norovirus vaccine. The Phase I/II study will assess safety and immunogenicity associated with LigoCyte's investigational, nasally-delivered, dry powder vaccine in healthy adults. The study will also assess potential protection against clinical symptoms of norovirus infection by including a live virus challenge of subjects that have received either the vaccine or placebo. Clinical studies to date have shown the vaccine to be immunogenic and generally well tolerated in human subjects.

"Norovirus infections are now being recognized as a widespread problem that can have very serious consequences," said Donald P. Beeman, CEO of LigoCyte. "The worldwide impact of this highly contagious virus has been increasingly appreciated with the continued closures of hospital wards, long-term care facilities, and schools."

Norovirus infection, well known as the "stomach flu," is the most common cause of acute gastroenteritis, afflicting nearly 23 million Americans annually. Norovirus infection is characterized by the acute onset of nausea, vomiting, abdominal cramps, diarrhea, and occasionally fever. Severe clinical outcomes are associated with at-risk populations, where complications caused by infection can disrupt primary treatment regimens and even lead to death. Noroviruses are highly infective and easily transmitted. Epidemic outbreaks occur in community environments, particularly hospitals, hotels, schools, and nursing homes, resulting in significant risk to immunocompromised individuals and mounting socioeconomic cost to families, the health care system and businesses. Military units are also affected, as outbreaks represent a significant readiness issue for naval vessels and land-based installations.

LigoCyte's norovirus vaccine is a needle-free, dry powder formulation based on virus like particle (VLP) antigens, which are highly purified protein products. By preserving the authentic conformation of the viral capsid, VLPs mimic the antigen presentation of the live virus while lacking the ability to reproduce or cause illness. LigoCyte's vaccine formulation also includes the adjuvant Monophosphoryl Lipid A, provided under license from GlaxoSmithKline (NYSE: GSK), and chitosan (ChiSys(R)) to enhance nasal delivery, under license from Archimedes Development Ltd. LigoCyte's challenge study will utilize a live Norwalk virus inoculum developed at Baylor College of Medicine with funding from the National Institutes of Health. Additional information about the study can be found at www.clinicaltrials.gov.

On September 9, 2009, Marcelo Sztein, M.D., Professor of Pediatrics and Medicine at the Center for Vaccine Development at the University of Maryland School of Medicine, will present safety and immunogenicity data on LigoCyte's norovirus vaccine at the 5th International Conference on Vaccines for Enteric Diseases (VED2009) in Malaga, Spain. Dr. Sztein's oral presentation will include clinical data on safety of the vaccine as well as serum immunoglobulin levels (IgG and IgA) resulting from vaccination.

About LigoCyte:

LigoCyte is an immunology company developing a new generation of vaccines for the prevention of infectious diseases. LigoCyte's expertise in virus-like particle vaccines supports a pipeline of enhanced products, including vaccines against norovirus, influenza and respiratory syncytial virus. The company is also developing antibody therapeutics against important chronic inflammatory diseases. For additional information on LigoCyte, please visit www.ligocyte.com.

ChiSys(R) is a trade mark of Archimedes Development Ltd., and is registered as an EU Community Trademark, as a US Registered Trademark and in certain other jurisdictions.


'/>"/>
SOURCE LigoCyte Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. LigoCyte Pharmaceuticals Announces Collaboration With Biogen Idec to Develop Anti-CD103 Therapies
2. Vion Pharmaceuticals Announces Results of the Oncologic Drugs Advisory Committee Meeting for Onrigin(TM)
3. Sagent Pharmaceuticals Announces Launch of Adenosine Injection, USP, in 6 mg per 2 mL Single-Dose Vials
4. ISTA Pharmaceuticals Announces Positive Preliminary Phase 3 Clinical Results to Support sNDA Filing for Once-Daily Xibrom(TM) 0.09%
5. NovaBay Pharmaceuticals to Present New Data on Lead Anti-Infective Compound at the 2009 ICAAC Annual Meeting
6. Impax Pharmaceuticals Selects OmniComm Systems to Provide eClinical Solutions for International Phase III Study in Parkinsons Disease
7. Amira Pharmaceuticals Submits IND for Second DP2 Antagonist, AM461
8. Adamas Pharmaceuticals Signs CRADA With U.S. Navy to Conduct Preclinical Studies of Triple-Combination Antiviral Drug Therapy for Influenza A, Including the Novel H1N1 Pandemic Strain
9. Eiger BioPharmaceuticals Announces Initiation of CLEAN-1 HCV Phase 1b Trial
10. Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program
11. Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... YORK , Jan. 23, 2017 ... detect, and control light. The interaction of these ... used in a wide range of applications. These ... aerospace and defense, telecommunications, and healthcare among others. ... primarily owing to its low power consumption, reliability, ...
(Date:1/24/2017)... VALLEY COTTAGE, New York , January 23, 2017 ... Projected to Witness Sluggish Growth ... world are derived from formulating Active Pharmaceutical Ingredients (API), ... isopropanol, propanol and propylene glycol. Production of ... Asia-Pacific excluding Japan ...
(Date:1/23/2017)... 2017  Therabron Therapeutics, Inc., a clinical-stage biotechnology ... respiratory care, today announced that the European Medicines ... granted Orphan Drug Designation for Therabron,s CG367 program, ... (BOS).  "We are pleased to have ... treat patients diagnosed with BOS following lung transplantation. ...
Breaking Medicine Technology:
(Date:1/24/2017)... ... January 23, 2017 , ... The Pharmacy and Medically Underserved ... bipartisan original co-sponsorship of nearly one-quarter of the U.S. House of Representatives. The ... Chain Drug Stores (NACDS) strongly backs the legislation. , “NACDS thanks for their ...
(Date:1/24/2017)... ... 23, 2017 , ... The TouchPoint Solution, parent company of ... into the product’s app. The data replicates and validates Co-Founder and Neuropsychologist ... 30 seconds of using Buzzies, people experienced a 74 percent reduction in their ...
(Date:1/23/2017)... York, NY (PRWEB) , ... January 23, 2017 , ... ... announced today that John J. Nelson, a senior accountant at the Firm, will participate ... of Make-A-Wish® Hudson Valley. Over 200 runners will race up 1,576 steps, a vertical ...
(Date:1/23/2017)... FL (PRWEB) , ... January 23, 2017 , ... Wooden and plastic balance boards have ... strength and improve balance. Kumo Board is the first and only balance board ... it to be soft and rigid at the same time as well as skill-level adjustable ...
(Date:1/23/2017)... ... 2017 , ... METTLER TOLEDO has announced the availability of ... PAT Tools . , Crystallization is a common step used during ... Chemists now spend more time developing better intermediate and final crystallization steps. ...
Breaking Medicine News(10 mins):